Oncolytics Biotech(R) Inc. Announces 2015 Year End Results

CALGARY, March 11, 2016 /CNW/ - Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the year ended December 31, 2015.

"In 2015 we continued to advance our clinical program, reporting survival data from single arm Phase 2 studies in non-small cell lung and pancreatic cancers, as well as early data from a pilot study in multiple myeloma," said Dr. Brad Thompson, President and CEO of Oncolytics. "During the year we began combination therapy studies with REOLYSIN® and agents that modulate the immune system. Enrollment in a GM-CSF and REOLYSIN® combination therapy study in pediatric patients with gliomas began, and we recently announced our first study looking at REOLYSIN® in combination with an immunotherapeutic checkpoint inhibitor in pancreatic cancer."

Selected Highlights

Since January 1, 2015, selected highlights announced by the Company include:

Clinical Program

  • Treatment of the first patients in a Phase Ib study of pembrolizumab (KEYTRUDA®) in combination with REOLYSIN® and chemotherapy in patients with advanced pancreatic adenocarcinoma, the Company's first trial examining REOLYSIN® in combination with a checkpoint inhibitor;
  • Start of enrollment in a Phase Ib study of REOLYSIN® combined with standard doses of bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (REO 019);
  • A poster presentation at the 57th American Society of Hematology titled "REOLYSIN® Combined with Carfilzomib for Treatment of Relapsed Multiple Myeloma Patients," which disclosed updated findings (originally presented at the 15th International Myeloma Workshop) from a pilot study (NCI-9603) in patients with relapsed or refractory multiple myeloma treated using the combination of carfilzomib and REOLYSIN®. These findings included that all seven patients treated at the full clinical dose had a clinical response, as well as significant increases in the production of caspase-3 (p=0.005) and upregulation of PD-L1 (p=0.005);
  • An oral presentation at the International Association for the Study of Lung Cancer (IASLC) 16th World Conference on Lung Cancer titled "Oncolytic Reovirus in Combination with Paclitaxel/Carboplatin in NSCLC Patients with Ras Activated Malignancies, Long Term Results," covering updated results, including one- and two-year survival data (57% and 30%, respectively), from the Company's REO 016 Phase 2 study in Non-Small Cell Lung Cancer (NSCLC);
  • Presentation of final data from a single arm clinical study examining the use of REOLYSIN® in combination with gemcitabine in patients with advanced pancreatic cancer (REO 017), which showed an increase in median overall survival, as well as an approximate two-fold increase in one-year survival rates, and a five-fold increase in two-year survival rates when compared to gemcitabine therapy alone as seen in historical data;
  • Completion of enrollment in three randomized Phase 2 studies sponsored and conducted by the NCIC Clinical Trials Group; IND 211 is a study of REOLYSIN® in combination with chemotherapy in patients with previously treated advanced or metastatic non-small cell lung cancer; IND 210 is a study of REOLYSIN® in patients with advanced or metastatic colorectal cancer; and IND 209 is a study of REOLYSIN® in combination with chemotherapy in patients with recurrent or metastatic castration resistant prostate cancer;
  • An update on the planned registration program for REOLYSIN® including an initial focus on two indications: the neoadjuvant treatment of muscle-invasive bladder cancer and the treatment of glioblastoma;
  • Activation of an Investigational New Drug Application containing the protocol titled "MC1472: Phase 1 Study of Replication Competent Reovirus (REOLYSIN®) in Combination with GM-CSF in Pediatric Patients with Relapsed or Refractory Brain Tumors";
  • Presentation of data showing up-regulation of PD-1 and PD-L1 from a single arm clinical study examining the use of REOLYSIN® in patients with primary glioblastomas or brain metastases (REO 013b) at the Royal Society of Medicine's Immuno-oncology: Using the Body's Own Weapons Conference, held in London, UK;

Regulatory

  • Granting of Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for REOLYSIN® in the treatment of pancreatic, gastric, ovarian, primary peritoneal, and fallopian tube cancers, as well as malignant gliomas;
  • Granting of Orphan Drug Designation by the European Medicines Agency for REOLYSIN® in the treatment of ovarian and pancreatic cancers;

Basic Research

  • Presentation of preclinical data at the 9th International Conference on Oncolytic Virus Therapeutics in Boston, MA, including findings around REOLYSIN®'s mechanism of action and its potential in new indications including chronic lymphocytic leukemia;
  • Presentation of clinical and preclinical data at the 2015 Immune Checkpoint Inhibitors Meeting in Boston, MA, including content showing the combination of REOLYSIN®, GM-CSF, anti-PD-1 and anti-CTLA-4 improved survival in immune competent mice versus REOLYSIN® and GM-CSF alone, and REOLYSIN® and GM-CSF plus either one of the checkpoint inhibitors alone;
  • A series of presentations made by the Company's research collaborators at the American Association for Cancer Research Annual Meeting held in Philadelphia, PA covering preclinical research in a range of indications, with a variety of treatment combinations including REOLYSIN®;

Financial

  • At December 31, 2015 the Company reported $26.1 million in cash, cash equivalents and short-term investments.  At March 10, 2016, the Company had approximately $23.6 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies as well as both a run-in and a registration study in muscle-invasive bladder cancer; and
  • Subsequent to year-end, entry into an "at-the-market" equity distribution agreement with Canaccord Genuity Corp. permitting Oncolytics at its sole discretion, from time to time and until March 16, 2018, to sell common shares having an aggregate offering value of up to $4.6 million.

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

     
As at December 31, 2015
$
2014
$
Assets    
Current assets    
Cash and cash equivalents 24,016,275   14,152,825  
Short-term investments 2,060,977   2,031,685  
Accounts receivable 340,059   191,751  
Prepaid expenses 506,669   291,553  
Total current assets 26,923,980   16,667,814  
     
Non-current assets    
Property and equipment 459,818   525,376  
Total non-current assets 459,818   525,376  
     
Total assets 27,383,798   17,193,190  

Liabilities And Shareholders' Equity
   
Current Liabilities    
Accounts payable and accrued liabilities 2,709,492   3,373,997  
Total current liabilities 2,709,492   3,373,997  

Shareholders' equity
   
Share capital        
  Authorized: unlimited   
Issued:  
December 31, 2015 - 118,151,622  
December 31, 2014 -   93,512,494
261,324,692   237,657,056  
Contributed surplus 26,277,966   25,848,429  
Accumulated other comprehensive income 760,978   280,043  
Accumulated deficit (263,689,330)   (249,966,335)  
Total shareholders' equity 24,674,306   13,819,193  
Total liabilities and equity 27,383,798   17,193,190  
         
       

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

 
For the years ending December 31, 2015
$
2014
$
2013
$
               
Expenses      
Research and development 8,601,864   13,824,252   18,506,064  
Operating 5,315,837   4,998,694   5,392,660  
Loss before the following (13,917,701)   (18,822,946)   (23,898,724)  
Interest 197,859   210,390   371,485  
Loss before income taxes (13,719,842)   (18,612,556)   (23,527,239)  
Income tax (expense) recovery (3,153)   (6,779)   (5,408)  
Net loss (13,722,995)   (18,619,335)   (23,532,647)  
Other comprehensive income items that may be  
reclassified to net loss
     
  Translation adjustment 480,935   200,345   136,813  
               
Net comprehensive loss (13,242,060)   (18,418,990)   (23,395,834)  
Basic and diluted loss per common share (0.12)   (0.21)   (0.28)  
               
Weighted average number of shares (basic and diluted) 112,613,845   87,869,149   83,530,981  
               
             

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

 
  Share Capital
$
Warrants
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Income
$
Accumulated
Deficit
$
Total
$
As at December 31, 2012 198,155,091   376,892   24,126,265   (57,115)   (207,814,353)   14,786,780  
             
Net loss and other comprehensive income       136,813   (23,532,647)   (23,395,834)  
Issued, pursuant to a bought deal financing 30,218,796           30,218,796  
Exercise of stock options 238,677     (59,437)       179,240  
Share based compensation     424,384       424,384  
As at December 31, 2013 228,612,564   376,892   24,491,212   79,698   (231,347,000)   22,213,366  
             
Net loss and other comprehensive income       200,345   (18,619,335)   (18,418,990)  
Issued, pursuant to Share Purchase Agreement 7,830,409           7,830,409  
Issued, pursuant to "At the Market" Agreement 1,214,083           1,214,083  
Expired warrants   (376,892)   376,892        
Share based compensation     980,325       980,325  
As at December 31, 2014 237,657,056     25,848,429   280,043   (249,966,335)   13,819,193  
             
Net loss and other comprehensive income       480,935   (13,722,995)   (13,242,060)  
Issued, pursuant to Share Purchase Agreement 4,305,396           4,305,396  
Issued, pursuant to "At the Market" Agreement 19,362,240           19,362,240  
Share based compensation     429,537       429,537  
As at December 31, 2015 261,324,692     26,277,966   760,978   (263,689,330)   24,674,306  
                         
                         

ONCOLYTICS BIOTECH INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

             
For the years ending December 31, 2015
$
2014
$
2013
$
       
Operating Activities      
Net loss for the year (13,722,995)   (18,619,335)   (23,532,647)  
Amortization - property and equipment 180,411   163,501   131,623  
Share based compensation 429,537   980,325   424,384  
Unrealized foreign exchange (gain) loss (816,319)   242,542   (89,721)  
Net change in non-cash working capital (1,105,464)   (2,443,988)   (1,374,172)  
Cash used in operating activities (15,034,830)   (19,676,955)   (24,440,533)  
Investing Activities      
Acquisition of property and equipment (108,268)   (152,750)   (254,834)  
Redemption (purchase) of short-term investments (29,292)   (30,041)   (32,416)  
Cash used in investing activities (137,560)   (182,791)   (287,250)  
             
Financing Activities      
Proceeds from exercise of stock options and warrants     179,240  
Proceeds from Share Purchase Agreement 4,305,396   7,830,409    
Proceeds from "At the Market" equity distribution  agreement 19,362,240   1,214,083    
Proceeds from public offering     30,218,796  
Cash provided by financing activities 23,667,636   9,044,492   30,398,036  
(Decrease) increase in cash 8,495,246   (10,815,254)   5,670,253  
Cash and cash equivalents, beginning of year 14,152,825   25,220,328   19,323,541  
Impact of foreign exchange on cash and cash equivalents 1,368,204   (252,249)   226,534  
Cash and cash equivalents, end of year 24,016,275   14,152,825   25,220,328  
             
             

To view the Company's Fiscal 2015 Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's annual filings, which will be available under the Company's profile at www.sedar.com and on Oncolytics' website at http://www.oncolyticsbiotech.com/investor-centre/financials/.

About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics.  Oncolytics' clinical program includes a variety of later-stage, randomized human trials in various indications using REOLYSIN®, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company's belief as to the potential of REOLYSIN® as a cancer therapeutic; the Company's expectations as to the success of its research and development programs in 2016 and beyond, the Company's planned operations, the value of the additional patents and intellectual property; the Company's expectations related to the applications of the patented technology; the Company's expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs; and other statements related to anticipated developments in the Company's business and technologies involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

  

SOURCE Oncolytics Biotech Inc.

For further information:

NATIONAL Equicom
Nick Hurst
800 6th Ave. SW, Suite 1600
Calgary, Alberta  T2P 3G3
Tel: 403.218.2835
Fax: 403.218.2830
nhurst@national.ca   


NATIONAL Equicom
Michael Moore
San Diego, CA
Tel: 858.886.7813
mmoore@national.ca 


Dian Griesel, Inc.
Susan Forman
335 West 38th Street, 3rd Floor
New York, NY  10018
Tel:  212.825.3210
Fax:  212.825.3229
sforman@dgicomm.com


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